Cytologic scraper

ABSTRACT

An apparatus adapted to be self-administered for obtaining surface cells from a human being, particularly from the vaginal and cervical areas of a female, for use in diagnosing cancer, the apparatus having a spatulalike scraper of heartlike configuration with two dissimilarly shaped lobes for taking a cellular smear, the scraper telescoping within a protective cover and being operable to be extended therefrom and to be rotated for cell collecting when the apparatus is disposed within the human body.

D United States Patent 3,592,186

72; Inventor ChodeOeter 3,352,299 ll/l967 Sagiroglu 123 2 16206 Addison, Soulhfleld, Mlcll. 48075 3,404,677 l0/l968 Springer r l a r r r a I28/2 [2|] Appl. No. 794,520 3,438,366 4/l969 Kariher et al l28l2 [22] Filed Jill. 28,1969 3,485,236 l2/l969 Frost l28/2 [4S] Patented July I3, [971 3,49l,747 [/1970 Robinson r. l28/2 OTHER REFERENCES SURGERY, GYNECOLOGY AND OBSTETRICS, Vol. (54] CYTODOGIC 8cm 87, No. 3, Sept. 1948, p, [8 (copy in SL335 128/213) 1 Chill, 6Drawing Flgs. Primary Examiner-Richard A. Gaudet Assistant Examiner- Kyle L. Howell [52] US. Cl. Anomey acmard D Bosdon ,[Sl] lll. A6") 10/00 [50] Flekld'seareh 128/128,

304 ABSTRACT: An apparatus adapted to be self-administered for obtaining surface cells from a human being, particularly Cm from the vaginal and cervical areas of a female, for use in diag- UNITED STATES PATENTS nosing cancer, the apparatus having a spatulalike scraper of D. 196,412 9/1963 Ayre 083/12 heartlike configuration with two dissimilarly shaped lobes for 217L088 5/1949 Ayre [28/304 taking a cellular smear, the scraper telescoping within a pro- 2,90$,l69 9/1959 Nieburgs..... l28/2 tective cover and being operable to be extended therefrom 2,955,591 Ill/I960 MacLean l28/B and to be rotated for cell collecting when the apparatus is 2.955.592 l0/l960 Macbean l28/2 disposed within the human body.

Z4 28 34 3 3 4 I Z6 t l I 6 30 J6 -i- 0 PATENTEI] JUL 1 3 I97:

INVENTOR CLAUDE OSTER CYTOLOGIC SCRAPER BACKGROUND OF THE INVENTION l. Field of the Invention This invention relates to a medical instrument for collecting cells from a female body for cytologic evaluation and, in particular, to an apparatus having a scraper and a protective cover engaged in a telescopic relationship for the scraper to extend therefrom and to collect, upon rotation, cells from surfaces contacted when the apparatus is disposed substantially within the female body.

2. Description of the Prior Art In the past, devices used to gather cells from both the vaginal and cervical areas of the female body for cytologic evaluation had to be inserted and operated by a person having a special skill, in order to preclude injury to the individual being examined. The prior art scraper devices are generally of a configuration and material which, if not handled by trained personnel, could result in a puncture or abrasive injury to the areas being examined. Further, those devices which purport to have elements which act to stop the scraper from being disposed unduly into the vaginal opening. either are not designed to gather cells from the immediately accessible potential growth areas of cancer in the vaginal and cervical regions or are ofsuch construction as to be inherently dangerous if not operated by a trained person.

SUMMARY OF THE INVENTION Accordingly. there is need for an apparatus capable of being self-administered for collecting cells from both the vaginal and cervical regions of the female body for cytologic evaluation. The present invention provides such an apparatus. The medical instrument of the present invention is particularly useful as a screening device and greatly facilitates the administration of medical attention and the conduction of examinations to large numbers of people, including those in remote areas of the world. The medical instrument comprises a substantially resilient scraper having a generally irregular heart-shape which is telescopically engaged with a protective cover. When the apparatus is disposed substantially within the female body at the vaginal opening, the scraper is extensible and rotatable by the individual from whom the cells are to be obtained. The scraper is shaped to collect cells from the walls of the vagina and the fornix and s portions of the cervix, regardless of the orientation of the cervix. An indexer is provided to give external indication to the operator of the relative position of the scraper when in operation.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of an example of an embodiment according to the principles of the present invention showing a scraper in an extended position;

FIG. 2 is a plan view of the exemplary embodiment illustrated in FIG. I, showing a scraper, a scraper handle and a cross section of a protective cover, with the scraper in a retracted position;

FIG. 3 is a cross-sectional view through FIG. 2 on the plane of the line 33, looking in the direction ofthe arrows;

FIG. 4 is a cross-sectional view through FIG. 2 on the plane of the line 4-4, looking in the direction of the arrows;

FIG. 5 is a cross-sectional view through FIG. 2 on the plane ofline 5-5, looking in the direction of the arrows; and

FIG. 6 is an illustration of the application of the apparatus illustrated in FIG. I showing a suggested method of holding during operation thereof and a fragmentary cross-sectional view of the vaginal and cervical areas of the female human body.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENT Since the apparatus is capable of being self-administered, it lends itself to widespread geographical use. It is now possible to effectively service remotely located areas which are still without medical facilities. Because of its intended universal use and because many of the areas have no sterilization equipment, it is practical that the apparatus be disposed of after a single use. Accordingly, its manufacturing design and the material used throughout, although in keeping with the purpose of the apparatus, are selected to minimize its cost. Addi tionally, it will be appreciated that the physical dimensions of a single unit apparatus are selected to accommodate the vast majority of the people.

Referring now to the drawings, FIG. 1 illustrates in perspective a cytologic scraping apparatus, generally shown at 10, having a scraper, generally shown at l2, extending from a cover 14. The extended position is the operative position and operation is accomplished by manipulation of a knob 16, which is connected to the scraper 12 through a handle 20 and on an intermediate shaft I8. The disposed relationship of the scraper 12, the intermediate shaft 18, the handle 20 and the knob I6 is best seen in FIG. 2.

Further to FIG. 2, wherein the apparatus is shown in plan view and in partial section, the cover 14 is of cylindrical configuration, preferably having thin substantially rigid wall construction. It is desirable that the cover 14 be relatively nonabsorbent and/or have a low rate of absorption, and to have a low coefficient of friction on its exterior surface when in contact with the human skin, in order to retain its configuration and to be applied without difficulty or discomfort. Optionally, the entrant end 24 of the cover 14 may be ferruled inwardly (not shown) as an added measure to facilitate its administration to the female body at the vaginal opening. The sectional view of FIG. 3, best illustrates longitudinally extending protruding ribs 25, which are optionally included to provide a gripping surface for use when the cytologic scraping apparatus 10 is being applied.

The inner surface of the cover 14 is slidably engaged with the handle 20 and in combination, they are of such material and size so as to maintain engagement under static conditions, but to be free to be rotated and slid one within the other when external force is applied. The handle 20, accordingly, is also cylindrical and is able to register its entire length within the cover 14, as illustrated in FIG. I.

Also shown in FIG. I, the knob 16 is in contact with the cover 14. As best seen in FIG. 2, the surfaces which meet to form that contact are surfaces 26 and 28 of the cover I4 and the knob 16, respectively. When the surfaces 26 and 28 are in contact, the scraper [2 cannot be extended farther into the body when in an operative position. This stop acts to preclude injury caused by undue penetration of the scraper 12. As will be appreciated, penetration of the scraper 12 is relative to the location of the cover 14. As is described hereinafter, the penetration depth of the cover 14 is readily controllable.

FIG. 4 is a section along the plane of the line 4-4 viewed in the direction of the arrows and best illustrates longitudinally extending ribs 30, similar in nature to the ribs 25, but of shorter length. The ribs 30 are provided to enable the knob 16 to be rotated without undue difficulty. Since after the cytologic scraping apparatus 10 is inserted into the vaginal opening of the female, the relative rotated position of the scraper 12 is no longer particularly evident, an indexer 32 is provided on the knob 16. Various views of the indexer 32 are shown in FIGS. 1, 2 and 4. In the absence of the ribs 30, the indexer 32 can also be used to aid in the rotation of the knob 16.

The intermediate shaft 18, as hereinabove mentioned, is connected and preferably integral with the handle 20 and the scraper 12. The shaft 18 and the scraper 12 are of suitable resilient material in order to flex a slight amount under normal operating forces and yet be rigid enough to scrape the areas of contact upon rotation. The intermediate shaft [8 is substantialiy cylindrical, as best seen in the sectional view of FIG. 5, and is free to flex equally in all directions upon exertion of a given force. At the junction of the intermediate shaft 18 and the scraper 12. the cylindrical shape of the intermediate shaft [8 is reduced into the area ofthe scraper 12. The scraper I2 is substantially flat and is in the shape of a heart having dissimilarly shaped lobes 34 and 36. The lobe 34 also takes on the appearance of a fin diagonally disposed to the longitudinal axis established by the shaft [8. The fin has an apex or outwardmost point of generally convex shape, and when viewed from the side has a slightly bulging appearance, as best seen in FIG. 5, which is a sectional view in the direction of the arrows at the plane of the line -5. The lobe 36 is of oblong shape with convex end and is similarly diagonally disposed to the axis established by the shaft 18. The lobe 36 extends a greater diagonal distance from the axis of the shaft 18 than does lobe 34. FIG. 5 also best shows the rounded and slightly bulging side view of the lobe 36.

[t is well accepted that a roughened surface texture is more desirable to collect cells from the vaginal and cervical regions of a female. Not all scraper instruments necessarily need have a roughened texture created thereon, since certain materials inherently have suitable surfaces. Certain grades of wood and gauze have been successfully used to collect cells from the areas under examination. The scraper 12, as illustrated in FIG. 2, has a rather extensive textured surface, which extends substantially up to the junction with the intermediate shaft 18. It will be appreciated that the texture plays a most important part along the outer perimeter of the lobes 34 and 36 and immediately to each side of the perimeter edge.

As mentioned hereinabove, the cytologic scraping apparatus 10 is particularly capable of being self-administered for vaginal and cervical examinations, and further it can be operated effectively regardless of the position assumed by the examined person as she operates the apparatus. Reliable results are obtainable whether the examined person is stand ing, squatting, sitting or lying.

In operation, the woman assumes a comfortable position and after having removed the cytologic scraping apparatus from its protective and sterile packaging, grasps the cover 14 at the end closest to the knob 16 with one hand and knob l6 with the other hand. HO. 6 illustrates the general area involved in the examination. She then, without undue force, inserts the apparatus into her body, entrant end 24 preceding, past the ulva 38 substantially into the vagina 40, practically until the hand grasping the cover [4 would need to release its grip if penetrated farther. Once the cover 14 is comfortably inside, the woman exerts slight force against the knob 16 thereby extending the scraper l2 farther into the vagina 40 until she senses that the scraper 12 cannot be extended farther or until the cover surface 26 and the knob surface 28 are in contact (FIG. 1). When the cover 14 has been properly positioned, the surface 26 and 28 will be able to be contacted and the apparatus is ready to be operated. This arrangement is best illustrated in FIG. 6 where the lobe 34 is in contact with the os 42 of the cervix 44 and the lobe 36 is in contact with the vaginal wall 46. The above-described arrangement will accommodate the majority ofwomen.

The knob 16 is now ready to be rotated and should be for a minimum of one full turn, taking note of the initial location of the indexer 32 so it can be returned to at least that position to accomplish one full turn. Because of the resilience of the scraper l2 and the intermediate shaft l8 and the freedom of the cover 14 to pivot slightly in its location, relatively little discomfort will be felt as the scraper 12 is rotated. The dissimilarly shaped lobes 34 and 36 are configured to contact the vaginal walls 46, the ectocervix 48 and the 0s 42 of the cervix 44 to allow the scraper 12 to collect cells on its roughened surface for cytologic evaluation. The scraper 12 is successful in collecting cells from the cervix 44 regardless of the orientation it may assume After a scraping has been accomplished, the knob X6 is urged outwardly thereby retracting the scraper 12 to assume a retracted position with respect to the cover [4, as best shown in FIG. 2. The woman then extracts the cytologic scraping apparatus 10 from her body and then presents it to a clinic aid for deposition of the cellular scraping upon a slide for cytologic examination. Alternatively, the woman could once again extend the scraper l2 and smear the scrapings from the lobes 34 and 36 upon a slide and apply a usual fixative thereto and send the slide, properly identified, to a laboratory for examination.

The ease of operation of the apparatus, the reliable results achieved through its use, the fact that it is capable of self-ad ministration and can be made inexpensively, renders this inventive apparatus a ideal instrument for screening great mul titudes of women to determine the existence or nonexistence of cancerous growth in the cervical and vaginal areas, This apparatus will enable medical personnel presently involved in conducting such examinations to devote their time to other critical matters. Because instruction in the use of the cytologic scraping apparatus 10 is possible through printed picture form on instructional sheets, the apparatus can be used by the literate and nonliterate alike, making it ideally suited to be used in remote underdeveloped areas of the world.

This invention is described by way ofillustration rather than limitation, and accordingly it is understood that this invention is to be limited only by the appended claim taken in view of the prior art.

I claim:

I. An apparatus for obtaining cells for cytologic examination, comprising:

an elongated body member having a central axis with a generally flexible scraper portion at one end of the body member and a handle at the opposite end, disposed between and integral with the scraper portion and the handle is an intermediate portion, the scraper end being formed of substantially nondeformable material defining a flat section and two lobe sections, the two lobe sections are of differing shape and each extends outwardly from the elongated body member defining a plane passing through the axis of the elongated body member, the lobes being of greater thickness in a direction extending trans versely to the plane than the flat section joining the lobes and integrally connecting the lobes to the intermediate portion, the lobes having a rough grained surface texture for obtaining cells, the intermediate portion having a flexible portion extending from the scraper end to a cylindrical portion extending therefrom to the handle, the handle having a circular cross section and protruding gripping ribs disposed about the circular periphery, the ribs extending in length in the direction of the axis of the elongated body member, the handle having an index tab protruding from the circular periphery of the handle outwardly beyond the gripping ribs; and

a tubular cover slidably engaging the elongated body member at the cylindrical portion, the tubular cover having protruding positive gripping ribs about its periphery, the ribs extending in length in the direction of the axis of the elongated body member, the elongated body member being slidable between a retracted position whereat the scraper portion is disposed substantially interiorally ofthe tubular cover and an extended position whereat the scraper portion is disposed substantially exteriorally of the tubular cover for rotational manipulation of the handle and the lobes at the scraper portion when the apparatus is disposed for obtaining cells for cytologic examination. 

1. An apparatus for obtaining cells for cytologic examination, comprising: an elongated body member having a central axis with a generally flexible scraper portion at one end of the body member and a handle at the opposite end, disposed between and integral with the scraper portion and the handle is an intermediate portion, the scraper end being formed of substantially nondeformable material defining a flat section and two lobe sections, the two lobe sections are of differing shape and each extends outwardly from the elongated body member defining a plane passing through the axis of the elongated body member, the lobes being of greater thickness in a direction extending transversely to the plane than the flat section joining the lobes and integrally connecting the lobes to the intermediate portion, the lobes having a rough grained surface texture for obtaining cells, the intermediate portion having a flexible portion extending from the scraper end to a cylindrical portion extending therefrom to the handle, the handle having a circular croSs section and protruding gripping ribs disposed about the circular periphery, the ribs extending in length in the direction of the axis of the elongated body member, the handle having an index tab protruding from the circular periphery of the handle outwardly beyond the gripping ribs; and a tubular cover slidably engaging the elongated body member at the cylindrical portion, the tubular cover having protruding positive gripping ribs about its periphery, the ribs extending in length in the direction of the axis of the elongated body member, the elongated body member being slidable between a retracted position whereat the scraper portion is disposed substantially interiorally of the tubular cover and an extended position whereat the scraper portion is disposed substantially exteriorally of the tubular cover for rotational manipulation of the handle and the lobes at the scraper portion when the apparatus is disposed for obtaining cells for cytologic examination. 